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Details for New Drug Application (NDA): 022460

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NDA 022460 describes JALYN, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the JALYN profile page.

The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for NDA: 022460

Tradename:
JALYN
Applicant:
Glaxosmithkline
Ingredient:
dutasteride; tamsulosin hydrochloride
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022460

Suppliers and Packaging for NDA: 022460

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL 022460 NDA GlaxoSmithKline LLC 0173-0809 0173-0809-13 30 CAPSULE in 1 BOTTLE (0173-0809-13)
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL 022460 NDA GlaxoSmithKline LLC 0173-0809 0173-0809-59 90 CAPSULE in 1 BOTTLE (0173-0809-59)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG;0.4MG
Approval Date:Jun 14, 2010TE:ABRLD:Yes
Patent:5,565,467Patent Expiration:Nov 20, 2015Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 022460

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,565,467► subscribe
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,998,427► subscribe
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,846,976► subscribe
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